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Washington Post: Bank Plans Probe of HIV Tests In India

October 13, 2007

By Carrie Johnson

World Bank officials will hire two independent consultants to investigate complaints about the reliability of HIV test kits in India, they said this week in response to allegations from a doctor who sounded alarms about faulty products.

Graeme Wheeler, the bank's managing director, and Kees Kostermans, a medical expert who oversees the bank's South Asia public health operations, did not say when the consultants would be hired. In correspondence with the doctor, they said it would take some time to complete a systematic review of the HIV test kit program in India.

The bank has poured hundreds of millions of dollars into India through programs intended to prevent the spread of the human immunodeficiency virus, which causes AIDS. Those efforts came under fresh scrutiny when Kunal Saha, an Ohio physician who traveled to India this year at the bank's request, said he uncovered documents suggesting that defective tests had produced high numbers of false negative results. Indians given false results could expose others to HIV, Saha said.

The documents that Saha cited date from 2004 and 2005, but he said he saw suspect kits still on the shelves of Indian medical facilities six months ago. Indian authorities filed criminal charges last year against a company that distributed the HIV tests.

Saha, who claims that medical negligence in India caused the death of his wife in 1998, faulted the bank for not moving swiftly enough to police the National AIDS Control Organization (NACO), an Indian group that receives money from the World Bank. He wants the bank and NACO to issue a wide-scale public health alert to inform people in India about problems with the tests.

"What is the point in assigning new consultants to re-visit the same issues?" Saha wrote in an e-mail to Wheeler yesterday. "It is regrettable that in spite of the grave nature of these complaints that obviously pose serious risk of transmitting HIV to innocent citizens in India, NACO has shown little inclination to act expeditiously to solve this issue."

In a telephone interview, Kostermans said the bank was working closely with Indian authorities to ensure the integrity of the HIV testing program. He said the bank needed to analyze a wider sample of data in order to identify and avoid problems in the future.

"He is a medical doctor, I am a medical doctor," Kostermans said of Saha. "We have the same concerns."

Kostermans, one of two bank officials who were briefed by Saha in August, said he did not know whether the consultants would interview Saha. He said that the documents Saha cited involve false negatives in second tests that were intended to confirm the results of previous tests. If the first two test results conflicted, third tests would be administered.

Finding people in India who may have been exposed to HIV could be a serious logistical challenge, given record-keeping lapses and the time that has passed, Kostermans said.

Beatrice Edwards, who is working with Saha and monitors the bank for the Government Accountability Project, a nonprofit public interest group in Washington, called the response insufficient.

"The major issue is to protect public health, not protect the reputation of NACO, which seems to be the priority," Edwards said.